Determination of Residual Solvents in LongdanXiegan Tablets by Headspace Capillary Gas Chromatography
(Objective)The aim is to establish a new method to determine the organic solvent residues of methanol and ethanol in Longdan Xiegan tablets.(Methods)Headspace capillary gas chromatography was used,and the column was an Agilent DB-624 capillary column(30 m×ϕ0.53 mm,3 μm);the detection conditions were:programmed temperature rise;inlet temperature was 220℃;detector(FID)temperature was 250℃;split injection,5∶1 split ratio was selected;headspace vial equilibration temperature was 85℃,equilibration time was 20 min.(Results)The two organic solvents,methanol and ethanol,were well separated with good linearity in the ranges of 1.0335~248.04 μg·mL-1(r=0.9997)and 1.0505~252.12 μg·mL-1(r=0.9996),respectively,and the average recoveries were 97.4%(RSD=1.7%,n=6),95.7%(RSD=1.6%,n=6).(Conclusion)The method has good repeatability,precision and recovery,and is simple,sensitive and selec-tive,which can provide a reference basis for the quality control of residual solvents of gentian diarrhea liver tablets.
Longdan Xiegan TabletMethanolEthanolResidual SolventHeadspace Capillary Gas Chromatography